Status:
TERMINATED
Lamivudine and Plasma Markers of Inflammation in Retinal Detachment
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Retinal Detachment
Rhegmatogenous Retinal Detachment
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
Brief Summary
The goal of this clinical trial is to test whether an oral medication (lamivudine) enters the eye and reduces blood markers of inflammation in people who undergo retinal detachment surgery (pars plana...
Detailed Description
Lamivudine is an anti-viral medication that has intrinsic anti-inflammatory properties that could be useful in the treatment of vitreoretinal disease. It is not known whether lamivudine enters the eye...
Eligibility Criteria
Inclusion
- Age ≥ 18 or ≤ 75 years
- Patients with rhegmatogenous retinal detachment that require vitrectomy surgery
Exclusion
- Previous pars plana vitrectomy in the affected eye
- Positive for Hepatitis B surface antigen or HIV antibodies, or history of Hepatitis B/HIV
- Pregnant or breast-feeding
- Liver disease or abnormal AST/ALT
- Renal impairment (Creatinine clearance \< 50)
- Diabetes with current use of insulin
- Anemia (Hemoglobin \<13.2 g/dL (male) or \< 11.6 g/dL (female))
- Unwilling to hold concurrent use of sorbitol or sorbitol-containing medications or products while taking study medication(including, but not limited to: blackberries, raspberries, strawberries, stone fruits, apples, avocados, sugar-free items such as chewing gum, hard candies, snack bars, frozen desserts, and chocolates, liquid and capsule/caplet analgesics, cough/cold/flu syrup, liquid and capsule/caplet pseudoephedrine, chewable antacid tablets, liquid and capsule allergy medications, motion sickness and nausea medications)
- Current use of trimethoprim-sulfamethoxazole
- Pancreatitis or history of pancreatitis
- Uncontrolled blood pressure (\> 160 mm Hg systolic or \>100 mm Hg diastolic) within the last 3 months, or current use of more than one anti-hypertensive medication
- History of stroke, myocardial infarction, or congestive heart failure
- Current vitreous hemorrhage that obscures view of retinal details
- Patients with a shallow anterior chamber or in whom anterior chamber paracentesis is considered unsafe
Key Trial Info
Start Date :
January 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 6 2024
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT06056596
Start Date
January 30 2024
End Date
September 6 2024
Last Update
September 19 2024
Active Locations (1)
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1
University of Wisconsin
Madison, Wisconsin, United States, 53705